Presentation on ASX Gems Conference on 21st June, page-145

Wow, you need to spend some time learning about the FDA approval process. MSB is applying for a BLA, Biologics License Application. Like all BLAs, it will be reviewed by FDA's Center for Biologics Evaluation and Research.

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber

Sometimes during the review process, FDA will seek advice from outside experts in the form of an advisory committee. At FDA's request during the initial BLA review in 2020, the Oncology Drugs Advisory Committee (ODAC) looked at Ryoncil and and gave the opinion (9-1) that Ryoncil was effective at treating acute steroid resistent GVHD in children. The question wasn't "should we approve this drug," but most ODAC members would tell you that this is the real advice being given.

Despite this advice, FDA issued a CRL. And then another one in 2023. There won't be any advisory committees involved in the review this time. Just FDA CBER reviewers deciding if all remaining concerns have been addressed (product potency assays). And then final decision by the boss, Peter Marks. As we have seen this past week, he sometimes overrules the advice of these CBER reviewers.